ArthroCare Announces Expanded FDA Clearance for Arthroscopic Surgery; Broadest Array of Specific Indications for Any Company Marketing Radio Frequency Arthroscopic Surgical Devices.Business Editors/Health & Medical Writers SUNNYVALE, Calif.--(BW HealthWire)--July 31, 2001 ArthroCare Corporation (Nasdaq:ARTC ARTC Arthrocare Corp (stock symbol) ARTC Australian Rail Track Corporation ARTC Air Route Traffic Control ARTC Association de la Recherche Theatrale au Canada ARTC Andean Root and Tuber Crops ) today announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted the company expanded clearance to market its proprietary Coblation(R)-based disposable surgical devices for over 40 specific arthroscopic indications in the knee, shoulder, wrist, ankle, elbow and hip. The expanded clearance covers approximately 160 orthopedic procedures and represents the broadest array of specific indications approved for any company marketing radio frequency surgical equipment for arthroscopic and orthopedic applications. Specific indications covered by the FDA's action include articular cartilage articular cartilage n. The cartilage covering the articular surfaces of the bones forming a synovial joint. Also called arthrodial cartilage, diarthrodial cartilage, investing cartilage. debridement Debridement Definition Debridement is the process of removing nonliving tissue from pressure ulcers, burns, and other wounds. Purpose Debridement speeds the healing of pressure ulcers, burns, and other wounds. , ACL/PCL repair, subacromial decompression, meniscectomy men·is·cec·to·my n. Excision of a meniscus, usually from the knee joint. meniscectomy (men´isek´t and chondroplasty. The company believes the expanded FDA clearances will allow ArthroCare to aggressively market its products for use in all cleared indications. Previously, the company's devices for arthroscopic surgery had been marketed under an FDA clearance for soft tissue resection, ablation, coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or and hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis)1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means. 2. in general arthroscopic and orthopedic procedures "We have been using ArthroCare's system for arthroscopic surgery in our practice for several years, " said Orrin Sherman MD, Assistant Professor and Chief of Sports Medicine, New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the -- Hospital for Joint Disease, Department of Orthopedic Surgery. "I am especially pleased with the amount of control I am able to achieve in delicate reconstructive procedures of the knee and shoulder. In my experience, the relatively low temperatures and controlled ablative ablative (ăb`lətĭv') [Lat.,=carrying off], in Latin grammar, the case used in a number of circumstances, particularly with certain prepositions and in locating place or time. The term is also used in the grammar of some languages (e.g. process significantly improves the level of care I can provide to my patients." "The expanded clearance will enhance our marketing efforts in a number of arthroscopic indications," said Michael A. Baker Michael Allen Baker (Captain, USN, Ret.) is the International Space Station Program Manager for International and Crew Operations, at NASA's Johnson Space Center. He is responsible for the coordination of program operations, integration and flight crew training and support , ArthroCare president and chief executive officer. "It is particularly useful in articular cartilage applications as it coincides with the initial presentation of our multi-center human clinical trial data on knee surgery, which should be published in coming months. The expanded clearance positions us to continue to grow our business and refine the indications and therapies we offer." Prospective multi-center human studies and a recently completed retrospective survey of over 4000 patients, which demonstrate the safety and performance of Coblation technology, are being prepared for publication. Recent podium presentations at the American Academy of Sports Medicine, the Arthroscopy Arthroscopy Definition Arthroscopy is the examination of a joint, specifically, the inside structures. The procedure is performed by inserting a specifically designed illuminated device into the joint through a small incision. Association of North America and the International Society of Arthroscopic Knee and Sports Medicine have also demonstrated continued excellent clinical experience with the company's arthroscopic surgical devices. Arthrocare markets a product line of Coblation-based surgical devices for arthroscopic orthopedic applications, including over 29 unique devices, with additional models planned for release later this year. The Company believes that over the past seven years, more than one million Coblation-based surgical devices have been used clinically in arthroscopic surgery throughout the world About ArthroCare ArthroCare's products allow surgeons to operate with a high level of precision and control, limiting damage to surrounding tissue. The company's products operate at lower temperatures than traditional electrosurgical or laser surgery tools and enable surgeons to remove, thermally treat, or sculpt sculpt v. sculpt·ed, sculpt·ing, sculpts v.tr. 1. To sculpture (an object). 2. To shape, mold, or fashion especially with artistry or precision: soft tissue and to seal bleeding vessels. ArthroCare is a medical device company that develops, manufactures and markets products based on its patented Coblation technology. ArthroCare's soft-tissue surgery systems consist of a controller unit and an assortment of single-use disposable devices that are specialized for specific types of surgery. The company believes its Coblation technology can replace the multiple surgical tools traditionally used in soft-tissue surgery with one multi-purpose surgical system. Coblation technology is applicable across many soft-tissue surgical markets. The company's strategy includes applying its patented Coblation technology to a broad range of soft-tissue surgical markets, including arthroscopic surgery, cosmetic surgery, ear, nose and throat surgery, spinal surgery, neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. , general surgery, and various cardiology applications. The company's website is www.arthrocare.com. Safe Harbor Statements Except for historical information, this press release includes forward-looking statements. These statements include, but are not limited to the company's belief that regulatory clearances will enhance the company's marketing efforts, the company's belief in the efficacy and safety of its products, the timing of publication of clinical results, and other statements that involve risks and uncertainties. These risks and uncertainties include, but are not limited to competitive risk, the company's dependence on its arthroscopic system, and the uncertainty of protecting the company's patent position. These and other risks and uncertainties are detailed from time to time in the company's Securities and Exchange Commission filings, including ArthroCare's Form 10-K for the year ended December 30, 2000 and the 10-Q for the quarter ended March 31, 2001. Forward-looking statements are indicated by words or phrases such as "anticipates", "estimates", "projects", "believes", "intends", "expects", and similar words and phrases Words and Phrases® A multivolume set of law books published by West Group containing thousands of judicial definitions of words and phrases, arranged alphabetically, from 1658 to the present. . Actual results may differ materially from management plans. |
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